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Sr. Quality Engineer

In Minnesota / United States

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Sr. Quality Engineer   

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JOB TITLE:
Sr. Quality Engineer
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Plymouth Minnesota / United States

JOB DESCRIPTION :

Hello ,

Hope you are doing great.

This is Rafi from Intellectt INC; we have an immediate opportunity. Please find the below Job Description and if you are interested or know someone please refer us, please forward your resume to raffi@intellectt.com.

Role: Sr. Quality Engineer

Location: Plymouth, Minnesota

Duration: 24 Months

Duties:

Primarily responsible for authoring, reviewing/auditing, and approving project documentation associated with the SDLC to support Corporate, Division, FDA, and other regulatory requirements.

This role is accountable for determining changes or improvements needed to support the QA System and business-driven objectives. In addition to these primary areas of focus, quality assurance will perform project work related to Infrastructure (Hardware or Layered Software Installations), Application quality, Compliance initiatives, Validations, Internal/supplier audits, CAPA system investigation, confirmation, or verification.

Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for implementing and maintaining the effectiveness of the quality system.

Accountable for ensuring that project documentation for the software development lifecycle (SDLC) is followed for quality and non-quality applications.

Provides project management for validation or SDLC activities including Client QA time estimates, Provides software validation / QA guidance to clients and QA team, Organizing validation or SDLC material for a library or electronic storage, Coordinate and/or lead validation review board meetings.

Responsible for assessing risk and applying risk-based approach strategies without compromising compliance.

Recommend system release readiness and generate key project deliverables that are approved by senior managers and reviewed by regulators.

Responsible for evaluating system (applications, layered software, & hardware) implementations or changes for impact on other systems.

Perform inter-and extra- audits divisional audits against Abbott Policies, Procedures, Processes, Guidelines, etc. under the guidance of senior QA staff.

Responsible for coordinating, facilitating, and reporting inspections or observations completed for or on CIT.

Recommend modification to CIT quality and non-quality systems and drive changes through the approval process.

Develop and maintain written policies and procedures were related to the SDLC.

Perform Quality Engineering function related to processing improvements, metrics collection and analysis, and adherence to defined Abbott practices.

Requirements:

Associates Degree or higher and minimum of 5 years, to include experience in one of the following areas

Experience: in a formal software development life cycle (5-9 years).

Experience: in the regulated software environment. (2-3 years)

Project Management in software experience (1-2 years)

Position Details

Apr 11, 2021
S16174660701012871
Minnesota / United States
Plymouth
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Sr. Quality Engineer    Apply

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Hello ,

Hope you are doing great.

This is Rafi from Intellectt INC; we have an immediate opportunity. Please find the below Job Description and if you are interested or know someone please refer us, please forward your resume to raffi@intellectt.com.

Role: Sr. Quality Engineer

Location: Plymouth, Minnesota

Duration: 24 Months

Duties:

Primarily responsible for authoring, reviewing/auditing, and approving project documentation associated with the SDLC to support Corporate, Division, FDA, and other regulatory requirements.

This role is accountable for determining changes or improvements needed to support the QA System and business-driven objectives. In addition to these primary areas of focus, quality assurance will perform project work related to Infrastructure (Hardware or Layered Software Installations), Application quality, Compliance initiatives, Validations, Internal/supplier audits, CAPA system investigation, confirmation, or verification.

Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for implementing and maintaining the effectiveness of the quality system.

Accountable for ensuring that project documentation for the software development lifecycle (SDLC) is followed for quality and non-quality applications.

Provides project management for validation or SDLC activities including Client QA time estimates, Provides software validation / QA guidance to clients and QA team, Organizing validation or SDLC material for a library or electronic storage, Coordinate and/or lead validation review board meetings.

Responsible for assessing risk and applying risk-based approach strategies without compromising compliance.

Recommend system release readiness and generate key project deliverables that are approved by senior managers and reviewed by regulators.

Responsible for evaluating system (applications, layered software, & hardware) implementations or changes for impact on other systems.

Perform inter-and extra- audits divisional audits against Abbott Policies, Procedures, Processes, Guidelines, etc. under the guidance of senior QA staff.

Responsible for coordinating, facilitating, and reporting inspections or observations completed for or on CIT.

Recommend modification to CIT quality and non-quality systems and drive changes through the approval process.

Develop and maintain written policies and procedures were related to the SDLC.

Perform Quality Engineering function related to processing improvements, metrics collection and analysis, and adherence to defined Abbott practices.

Requirements:

Associates Degree or higher and minimum of 5 years, to include experience in one of the following areas

Experience: in a formal software development life cycle (5-9 years).

Experience: in the regulated software environment. (2-3 years)

Project Management in software experience (1-2 years)